N/A
N=32
In Vivo Recovery and Survival Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT03097289 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Recovered Percentage of the Extrapolated Platelet Count at Time 0 — 45.15; 56.02 percent of extrapolated platelet count
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trima Accel system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Terumo BCT
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recovered Percentage of the Extrapolated Platelet Count at Time 0 |
45.15; 56.02 | — |
| PRIMARY Number of Days of Platelet Survival |
5.40; 7.93 | — |
Summary
The purpose of this study is to evaluate the quality of platelets collected on the Trima Accel system after storage for 5 days in a Platelet Additive Solution (PAS), called InterSol.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Normal health status as per AABB criteria for a healthy donor
- Able to commit to the study schedule
- Meets the inclusion criteria defined by the Blood Center for an apheresis platelet with PAS collection on the Trima Accel system. These criteria are based on FDA Regulations and AABB standards. Note: Participants who are deferred from volunteer community donations because of travel restrictions, piercings, or tattoos may participate in the study, as products are not transfused
- Participants of child-bearing potential (either male or female) must agree to use an effective method of contraception during the course of the study
- Female of childbearing potential must be willing to take a pregnancy test prior to infusion of radiolabeled platelets
- Has given written informed consent
Exclusion Criteria
- Previously received radiation therapy
- Has been diagnosed with a platelet disorder (ie, platelet dysfunction)
- Already participated in 4 research studies involving radioisotopes within the contemporaneous calendar-year
- Pregnant or nursing females
- Participation currently, or within the last 12 months, in another investigational trial that would potentially interfere with the analysis of this investigation
- History of known hypersensitivity to indium or chromium
- Treatment with aspirin or aspirin containing medications within 7 days of apheresis or treatment with non-steroidal anti inflammatory drugs (NSAID), anti-platelet agents or other drugs affecting platelet viability within 3 days of apheresis (eg, ibuprofen or other NSAIDs)
Data sourced from ClinicalTrials.gov (NCT03097289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.